Antiretroviral therapy in resource limited settings: Responding to the

WHO 2010 guidelinesSylvia Ojoo

Assistant Clinical Professor of Medicine University of Maryland, Baltimore

Country Director, UMB Programs/Kenya

Outline

• Current status and progress of ART in RLS• Operational challenges to implementing

revised WHO treatment guidelines • Recommendations for sustaining expansion of

treatment while maintaining effectiveness

Current status: ART coverage averages 44% in SSA

Source WHO: Towards universal progress report July 2010

Number of people receiving ART in low- and middle-income countries, by region, 2002–

2008

Zambia

Botswana

Current status: patient clinical outcomes

Source WHO: Towards universal progress report July 2010

Retention on ART in low- and middle-income countries by region, 2008

Source AIDSRelief Kenya Continuous Quality Improvement

UNAIDS December 2009

Global summary of the AIDS epidemic, 2008

Total 33.4 million [31.1 – 35.8 million] Adults 31.3 million [29.2 – 33.7 million] Women (aged 15 and above)

15.7 million [14.2 – 17.2 million] Children under 15 years

2.1 million [1.2 – 2.9 million]

Total 2.7 million [2.4 – 3.0 million]Adults 2.3 million [2.0 – 2.5 million]Children under 15 years 430 000 [240 000 – 610 000]

Total 2.0 million [1.7 – 2.4 million]Adults 1.7 million [1.4 – 2.1 million]Children under 15 years 280 000 [150 000 – 410 000]

Number of people living with HIV in 2008

People newly infected with HIV in 2008

AIDS-related deaths in 2008

Zambia

When to start ART

All adolescents and adults including pregnant women with HIV infection and CD4 counts 350 cells/mm3. WHO clinical stage 3 or 4 (severe disease) should start ART irrespective of their CD4 cell count.

What to use in 1st line

First-line therapy should consist of an NNRTI + two NRTIs, one of which should be zidovudine (AZT) or tenofovir (TDF). Countries should take steps to reduce (and eventually eliminate) the use of stavudine (d4T) in first-line regimens because of its well recognized toxicities

Laboratory monitoring

All patients should have access to CD4-cell–count testing. HIV-RNA (viral-load) recommended to confirm suspected treatment failure. Symptom directed drug toxicity monitoring.

HIV/TB co-infection

Irrespective of CD4-cell counts, patients co-infected with HIV and tuberculosis (TB) should be started on ART as soon as possible after starting TB treatment.

2010 WHO ART Guidelines – Key Recommendations

In 2010 among 38 countries with available data:

• 34 countries in process of adopting CD4 threshold ≤ 350 cells/mm3

29 countries for all patients: Benin, Burkina Faso, Cameroon, CAR, Chad, China , Congo, Côte d'Ivoire, Eritrea, Ghana, Indonesia, Iran, Kenya, Lesotho, Malawi, Mali, Morocco, Moldova, PNG, Saudi Arabia*, Rwanda*, Seychelles*, Senegal, Swaziland, Tanzania, Togo, Ukraine, Zambia, Zimbabwe

3 countries for pregnant women: Botswana (other patients CD4 ≤ 250 cells/mm3), South Africa (other patients CD4 ≤ 250 cells/mm3), DRC.

2 countries are planning the adoption in 2011 : Burundi, Djibouti

• 4 countries are in process of decision (by end 2010): Ethiopia, India, Mozambique, Uganda Source: WHO survey 2010 on ARV use, June 1st, 2010

Many countries are adopting these recommendations

What have countries had to consider in implementing the

guidelines?

1. Increased number of patients needing treatment

• Increase in the number of patients who need treatment based on a lower threshold for treatment initiation (10-50%)

• Impact on extant health systems and infrastructure

0

100,000

200,000

300,000

400,000

500,000

600,000

4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

# of patients alive on ART # of patients alive on ART (new)# in need of ARTPoly. (# of patients alive on ART )

Malawi projections on treatment needs with and without the changes in guidelines.

(Source: Dr Zengani Chirwa , Malawi MOH)

2. HIV testing: the gap

Source: MOH, Kenya

Knowledge of Status: Kenya AIDS Indicator Survey 2007Treatment status of patients with CD4 <250

Source: MOH, Kenya

3. Access to CD4 testing

• Current levels variable– Malawi reporting about 20%– Kenya 75% receiving baseline in

2007– Universal in countries like

Botswana

• Countries anticipate significant investment in developing appropriate capacity and improving quality of tests

• Currently the majority of patients entering care already have low CD4 count

Median CD4 count at baseline count of 36 715 adults starting ART between 2001 and 2006

4. Costs! Median annual cost of first-line ARV drug regimens in low-income countries

by year, 2004–2008

> 34% of countries in SSA reported drug stock outs in 2008Source WHO: Towards universal progress report July 2010

5. Phasing out stavudine1st line regimens used in 2.4 million adults in 36 low and middle income countries,

December 2008

“Dilemma over toxic HIV drug” An Aids patient takes her daily dose of life-saving anti-retroviral (ARV) drugs. Photos/FILE  

By ARTHUR OKWEMBAPosted Saturday, December 5 2009 Daily Nation http://www.nation.co.ke/News/-/1056/818128/-/vnkle7/-/index.html

Recommendations for sustaining expansion of treatment while maintaining effectiveness

1. Resource mobilization and effective resource utilization

• Effective utilization of extant resources from donors and bilateral partners

• Governments to increase overall health expenditure (as per Abuja agreement) including that going into HIV care and treatment

• Expand private HIV care services and private investment in health

2. Effective approaches to HTC: e.g. family-centered testing

• Each patient enrolled in the clinic has a family enquiry form filled

• HIV test recommended and facilitated for all spouses and children < 15 yr– 8% of 125 children

tested were HIV positive

– 69% of 53 sexual partners tested were HIV positive

– 31% of spouses in discordant partnerships

• Better care and retention of non-ART patients

Lwak Hospital, Nyanza 2009

Source; AIDSRelief CQI Program, Kenya 2009

Identified Tested HIV+0

50

100

150

200

250

children <15 spouses Series3

3. Improving the chronic care model

– Accessible and usable patient care data

– Clear patient care standards that cover the full range of effective prevention, care and treatment interventions that have been demonstrated to work

– Chronic care model that puts community front and center

Source: AIDSRelief Kenya CQI Program

4. Health systems• Human resource capacity

– Review legal and policy environment

– Involvement of /leadership by institutions of higher learning

– Effective pre-service preparation of HCWs

– Development of innovative in-service support programs to allow effective dissemination of new practices etc

– Management to support all health interventions at facility level

• Greater integration of patient care services

• Institutionalization of gains made including chronic care paradigm

• Infrastructure to support guidelines including space and labs (CD4 with QA; Viral RNA services)

• Innovations!

Jaffar S, Amuron B, Levin J, et al.

5. Evidence based innovations

Conclusion

• Countries have been responsive and are committed to implementing the revised guidelines

• Challenges that exist in doing this have been part of the landscape to varying degrees across countries since scale up began– If not addressed, sustainable expansion of services

while maintaining quality may not be possible• These challenges are not insurmountable….